If the US natural products industry values its ability to keep a diverse range of products available for the benefit of the American public, and believes in not exposing the public to unnecessary costs, we strongly suggest that it look very closely at the latest guidelines from the FDA—with eyes wide open. We refer to the FDA guidelines on so-called “new dietary ingredients” (NDIs) that we’ve been telling you about over the past several weeks. These guidelines preempt a crackdown on ingredients used in natural products, one that appears to be coordinated closely with a similar clampdown happening currently in Europe.

The justification given for the new guidelines is—as is always the case when facing a tighter regulatory noose around dietary supplements—consumer safety. This of course brings about a predictable response from the natural health sector: “But where are the dead bodies?” It’s actually quite a pertinent question, and one that is rarely taken seriously by the FDA or other regulators.

A careful examination of the most recent two years of US National Poison Data System (NPDS) figures reveals that, of all products to which we are exposed that might cause harm, pharmaceutical drugs caused 80% and 81% of fatalities, respectively. The majority of these were from unintentional poisoning. Are you surprised? It makes it even more of a wonder that regulators continue to try to convince the public that pharmaceutical-like regulation will be the best way of guaranteeing their safety!

The NPDS data, combined with other data from the Centers for Disease Control and Prevention (CDC), shows emphatically that botanicals and dietary supplements are the safest products that we put in our mouths. This is especially the case given that they are almost never associated with nasty pathogenic bacteria in food, which cause millions of Americans to be hospitalized and thousands to die each year.  Actually, deaths associated with dietary supplements are extremely rare.

What the NDI guidelines force companies to do, once an ingredient is deemed to fit the NDI classification, is prove its safety before it can be sold. This notion is fundamental, because it moves us away from the long-cherished notion of presumption of safety for natural dietary ingredients, and places the burden of proof on the manufacturer. It actually may sound quite reasonable to some, but the reality is that proving safety is a very complex process—and one that is simply out of reach of most of the smaller companies that have been at the forefront of pioneering the natural health foods revolution since the 1960s.

This article serves as a distress call to practitioners and citizens who rely on diverse natural ingredients for healthcare. In Europe, there are two main ways that regulators are forcing products off the market. Either they get declared unlicensed drugs, or they get classified as unauthorized “novel foods.” In our experience of these problems in the EU, the novel food bans are proving at least as important a tool for the regulators as unlicensed drug classifications. Well, now it’s the FDA’s turn to use this same weapon on its people!

If you have not done so already, please send your message to Congress. Both these issues are monumentally important if you want to maintain your access to natural supplements.

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